Batrafen

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ciclopirox olamine 1%{relative}

Available from:

sanofi-aventis new zealand limited

INN (International Name):

Ciclopirox olamine 1% w/v

Dosage:

1% w/v

Pharmaceutical form:

Topical solution

Composition:

Active: Ciclopirox olamine 1%{relative}

Units in package:

Bottle, plastic, 1x20ml, 20 mL

Class:

Pharmacy only

Prescription type:

Pharmacy only

Manufactured by:

Sanofi-Aventis Deutschland GmbH

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, 1x20ml - 20 mL - 48 months from date of manufacture stored at or below 25°C

Authorization date:

1986-09-18

Patient Information leaflet

BATRAFEN CMI CRE & SOL 
#78119v2.0 
Page 1 

Batrafen
®
 Cream and Solution 
(bat-rar-fen)

_CICLOPIROX _
_(SICK-LOW-PIR-ROCKS)_
_ _
CONSUMER MEDICINE INFORMATION (CMI) 

WHAT IS IN THIS LEAFLET 
This leaflet answers some common 
questions about Batrafen. 
It does not contain all the available 
information. It does not take the 
place of talking to your doctor or 
pharmacist. 
All medicines have risks and 
benefits. Your doctor or pharmacist 
has weighed the risks of you using it 
against the benefits they expect it 
will have for you. 
IF YOU HAVE ANY CONCERNS ABOUT 
USING THIS MEDICINE, ASK YOUR 
DOCTOR OR PHARMACIST. 
KEEP THIS LEAFLET WITH THE MEDICINE. 
You may need to read it again. 
WHAT BATRAFEN IS USED 
FOR 
Batrafen contains ciclopirox, which 
is an antifungal agent. Batrafen is 
used to treat fungal infections of the 
skin. 
ASK YOUR DOCTOR OR PHARMACIST IF 
YOU HAVE ANY QUESTIONS ABOUT WHY 
IT HAS BEEN RECOMMENDED FOR YOU. 
BEFORE YOU USE IT 
_WHEN YOU MUST NOT USE IT _
DO NOT USE BATRAFEN IF YOU ARE 
ALLERGIC TO IT OR ANY OF THE 
INGREDIENTS LISTED AT THE END OF THIS 
LEAFLET. 
Some symptoms of an allergic 
reaction include skin rash, itching, 
shortness of breath or swelling of the 
face, lips or tongue, which may cause 
difficulty in swallowing or breathing. 
DO NOT GIVE BATRAFEN TO A CHILD. 
DO NOT USE IT IF YOU ARE PREGNANT OR 
INTEND TO BECOME PREGNANT. 
It may affect your developing baby if 
you use it during pregnancy. 
DO NOT USE IT IF YOU ARE BREAST-
FEEDING OR PLANNING TO BREAST-FEED. 
Batrafen may pass into breast milk 
and there is a possibility your baby 
may be affected. 
DO NOT USE BATRAFEN CREAM WITH 
LATEX CONDOMS. 
It contains a paraffin which can 
cause leaking or breaking of latex 
condoms and therefore lose the 
protection provided by condoms. 
DO NOT USE IT AFTER THE EXPIRY DA

Summary of Product characteristics

_Batrafen DS CRE & SOL_
_ _
_#78117v2.0 Page _
_1 _
_ _

DATA SHEET 
BATRAFEN CREAM AND SOLUTION 
NAME OF MEDICINE 
Ciclopirox olamine 1% cream and 1% w/v solution. 
PRESENTATION 
Batrafen Cream is a nearly white cream and each gram
contains 10mg ciclopirox olamine in an oil-
in-water emulsion consisting of 2-octyldodecanol, mineral
oil, stearyl alcohol, cetyl alcohol, 
polysorbate 60, myristyl alcohol,
cocamide DEA, sorbitan monostearate, lactic acid, purified water 
and benzyl alcohol (1%). 
Batrafen Solution is a clear solution and each
ml contains 10mg ciclopirox olamine dissolved in 
alcoholic aqueous solution. 
USES 
ACTIONS 
Ciclopirox olamine is a broad spectrum antimycotic with a high
penetrating power.  It has a 
fungicidal effect on dermatophytes, yeasts, moulds and other
fungi. 
PHARMACOKINETICS 
Penetration studies in human cadaverous skin from the back,
with Batrafen Cream 1% tagged with 
ciclopirox olamine, showed the presence of 0.8 to
1.6% of the dose in stratum corneum, 1.5 to 
6 hours after application. 
The levels in the dermis were still 10 to 15 times above the
minimum inhibitory concentrations. 
Three grams of the 1% solution were applied topically
to an area of about 750 square centimetres 
on the back of male subjects for 6 hours.  During this time
the serum concentration rose to 
0.008 ± 0.005 
μg/mL.  Three to 6 hours after removal of the solution,
the concentrations had 
already fallen below the detection limit of 0.003 
μg/mL. 
Of the radioactivity applied, 1.1 ± 0.6% was eliminated in the
urine and <0.1% in the faeces; the 
elimination half life was 3.5 ± 1.1 H on the first day.  Excretion
was complete on the second and 
third day.  The absorption which can be regarded as equal with
the portion of 1.1 ± 0.6% 
eliminated in the urine, practically ended when the active substance
was removed from the skin. 
INDICATIONS 
Batraf